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Идёт набор NCT07109440

The Role of the Imaging FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases

Без фазы С лечением Liver Metastases From Colorectal Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: FAPI PET/CT.
Кому может быть актуально
Состояния в реестре: Liver Metastases From Colorectal Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Role of FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases: Non-randomized Phase II Molecular Imaging Study

Обзор

FAPI PET/CT molecular imaging represents a cutting-edge advancement in oncological imaging, particularly for the preoperative assessment of colorectal liver metastases (CRLM). Fibroblast activation protein inhibitors (FAPIs), which are the focus of this imaging modality, selectively target cancer-associated fibroblasts, a critical component of the tumor microenvironment. FAPI PET/CT could be useful in the detection of HGP (Histological Growth Pattern) and in the changes during neoadjuvant chemotherapy prior to surgery

Подробное описание

The tumor microenvironment (TME) plays an important role in tumor development and therapeutic response. The understanding of the TME components, especially cancer-associated fibroblasts (CAFs) remains limited. CAFs are among the most abundant and versatile components of the tumor stroma and they are implicated in all the hallmarks of cancer. They have a heterogenous phenotype within a single cell. Some CAFs may have immunosuppressive properties. In liver, there are two obvious physiological sources of CAFs: resident portal fibroblasts (PFs) and hepatic stellate cells (HSCs) . A recent study showed that based on the gene expression profile there are three major subsets of CAFs in colorectal primary tumors and in liver metastasis, including secretory CAFs, ECM-remodeling CAFs and contractile CAFs . In patients undergoing resection of colorectal liver metastasis (CRLMs) the histological growth patterns (HGP) reflect tumor biology and local infiltrating behavior . The HGPs of liver metastases reflect the ways in which cancer cells interact with the surrounding liver. The transition from one HGP to another could occur in patients with CRLM following systemic treatment .

FAPI PET/CT molecular imaging represents a cutting-edge advancement in oncological imaging, particularly for the preoperative assessment of colorectal liver metastases (CRLM). Fibroblast activation protein inhibitors (FAPIs), which are the focus of this imaging modality, selectively target cancer-associated fibroblasts, a critical component of the tumor microenvironment. FAPI PET/CT could be useful in the detection of HGP and in the changes during neoadjuvant chemotherapy prior to surgery

Вмешательства

  • Диагностический тест FAPI PET/CT
    Patient will undergo FAPI PET/CT Prior to surgery

Первичные конечные точки

  • The quantification of IHC staining for FAP-expressing CAFs measured in patient-derived tissue specimens [Срок оценки: from the enrollement to the surgery date, approximately 3 to 4 weeks]
  • The quantification of FAP expression on FAPI PET/CT (SUVmax, SUVmean, MTV [metabolically active tumor volume], FAPI-TV [FAPI positive tumour load]) [Срок оценки: From enrollment to surgery date, approximately 3 to 4 weeks]
  • correlation between the value of FAPI PET/CT and the percent encapsulated, and the HGP scores (desmoplastic, replacement, pushing) of the liver metastasis [Срок оценки: from the enrollment to the anapathological analysis date,approximately 4 to 5 weeks]
Вторичные конечные точки (2)
  • Correlation between FAPI PET/CT and FDG PET/CT parameters: (SUV max, SUVmean, metabolical volume) [Срок оценки: from enrollment to the surgery date, approximately 3 to 4 weeks]
  • Correlation between FAPI metabolical volume and MRI tumor volume [Срок оценки: from enrollment to the surgery date, approximately 3 to 4 weeks]

Критерии участия

Критерии включения

  • Age above 18 years.
  • Liver metastasis on standard imaging for the initial assessment (MRI, FDG PET/CT)
  • Naïve for treatment or after neoadjuvant chemotherapy
  • Scheduled for liver metastasis resection
  • ECOG Performance status ≤2.
  • Signed written informed consent

Критерии исключения

  • Non-resectable liver metastases
  • Pregnant and lactating women
  • Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Бельгия · 1 центр
  • Institut Jules Bordet — Brussels

Идентификаторы

NCT: NCT07109440 · IJB-NM-FOAM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗